Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05750043 |
Other study ID # |
Project Code AID 011898 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 1, 2018 |
Est. completion date |
February 19, 2023 |
Study information
Verified date |
November 2023 |
Source |
Universiteit Antwerpen |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
For the first time using a prospective design, a study confirms the results of previous
retrospective studies, which found that strengthening onchocerciasis elimination efforts
decreases the incidence of epilepsy, including nodding syndrome. Therefore, this study
confirms the solid epidemiological link between onchocerciasis and epilepsy.
This study also shows that a community-based "Slash and Clear" vector control method can
effectively decrease blackfly biting rates and potentially decrease onchocerciasis
transmission.
Moreover, this study shows that epilepsy is a major cause of death in onchocerciasis endemic
areas with high ongoing transmission.
Description:
Background High onchocerciasis transmission predisposes communities in endemic areas to a
high epilepsy burden. The 4·4% (95%CI:4·1-4·7%) epilepsy prevalence documented in 2018 in
Maridi, South Sudan, motivated the strengthening of onchocerciasis elimination measures. We
evaluated the effect of these interventions on the incidence of epilepsy, including nodding
syndrome (NS).
Methods Annual community-directed treatment with ivermectin (CDTi) was implemented in 2019,
temporarily interrupted in 2020 and reimplemented biannually in 2021. Additionally, a
community-based "Slash and Clear" vector control method was initiated in 2019 at the Maridi
dam. A two-stage house-to-house survey was conducted before (2018) and after (2022)
implementing the interventions, consisting of initial screening by community workers to
detect suspected cases of epilepsy, followed by confirmation of the diagnosis by a trained
clinician.
Finding Overall, 17,652 and 14,402 individuals participated in the pre- and post-intervention
surveys, respectively. The epilepsy incidence decreased from 313·0 (95% confidence intervals
(CI):273·7-357·7) to 34·7 (95%CI:17·6-66·1) per 100,000 person-years. Similarly, the
incidence of NS decreased from 120·4 (95%CI:96·7-149·6) to 10·4 (95%CI:2·7-33·2) per 100,000
person-years. Despite biannual CDTi, only 56·6% of the population took ivermectin in 2021.
Mortality of persons with epilepsy accounted for 17·1% (95%CI:14·0-20·7%) of the overall
number of deaths in the population.
Interpretation In onchocerciasis-endemic areas with high prevalence of epilepsy,
strengthening onchocerciasis elimination interventions can decrease the incidence of
epilepsy, including NS. Additional efforts are needed in Maridi, where epilepsy is a major
cause of mortality, to increase CDTi coverage and sustain blackfly control.